Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom RX Imola, Model Nos. RX4900 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RX Imola, Model Nos. RX4900
Brand
Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
Lot Codes / Batch Numbers
All serial numbers
Products Sold
All serial numbers
Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom is recalling RX Imola, Model Nos. RX4900 due to There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damag. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
Recommended Action
Per FDA guidance
On June 24, 2019, the firm notified its customers of the recall through an Urgent Field Safety Notice. Customers were asked to take the following actions: If there is any sign of damage to the RCU lid or lid sensor " Switch of main analyser main power supply as soon as possible " Contact technical support immediately. " Discuss the contents of this notice with your Medical Director. " Display this notice in a prominent location near the instrument. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, MD, MA, MO, NJ, NY, NC, OH, PA, UT, WV, PR
Page updated: Jan 10, 2026